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AAMI TIR80001-2-5

2014 Edition, January 1, 2014

Complete Document

Application of risk management for ITnetworks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems



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SAME AS IEC 80001-2-5
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Description / Abstract:

This part of IEC 80001, which is a technical report, gives guidance and practical techniques for RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the RISK MANAGEMENT of DISTRIBUTED ALARM SYSTEMS. This technical report applies to the transmission of ALARM CONDITIONS between SOURCES, INTEGRATOR and COMMUNICATORS where at least one SOURCE is a MEDICAL DEVICE and at least one communication path utilizes a MEDICAL IT-NETWORK.

This technical report provides recommendations for the integration, communication of responses and REDIRECTION (to another OPERATOR) of ALARM CONDITIONS from one or more SOURCES to ensure SAFETY and EFFECTIVENESS. DATA AND SYSTEMS SECURITY is an important consideration for the RISK MANAGEMENT of DISTRIBUTED ALARM SYSTEMS. Figure 2 illustrates the functions of a MEDICAL IT-NETWORK incorporating SOURCES, an INTEGRATOR and COMMUNICATORS to distribute ALARM CONDITIONS.